search
Back to results

Levothyroxine Treatment in Thyroid Benign Nodular Goiter

Primary Purpose

Thyroid Nodule

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Levothyroxin treatment
Sponsored by
National Taiwan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Thyroid Nodule

Eligibility Criteria

20 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. age between 20 to 90 years old
  2. Benign nodular goiter diagnosed with thyroid echo and fine-needle - aspiration cytology

Exclusion Criteria:

  1. Age younger than 20 or older than 90 years old
  2. Pregnancy
  3. Allergy to eltroxin
  4. Taking other drugs which will have drug interaction with eltroxin
  5. patients with cardiovascular disease, hypertension, gastrointestinal disease

Sites / Locations

  • National Taiwan University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

under eltroxin

Outcomes

Primary Outcome Measures

The size of thyroid nodules

Secondary Outcome Measures

Full Information

First Posted
October 30, 2007
Last Updated
December 21, 2010
Sponsor
National Taiwan University Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT00552253
Brief Title
Levothyroxine Treatment in Thyroid Benign Nodular Goiter
Official Title
Levothyroxine Treatment in Thyroid Benign Nodular Goiter
Study Type
Interventional

2. Study Status

Record Verification Date
December 2010
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
July 2008 (Actual)
Study Completion Date
July 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Taiwan University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
We will study the effect of taking eltroxin at different time, i.e. fasting or postprandial periods. We will also study the effect of levothyroxin treatment in Chinese people
Detailed Description
OBJECTIVE - Current treatment of benign thyroid is oral levothyroxin by suppression of thyrotropin secretion and so that tumor growth. Although current consensus is taking thyroxin one hour before meal because the PH value of gastrointestinal tract will affect drug absorption, some patient suffered from epigastric discomfort when taking thyroxin with empty stomach, and wish to take it postprandial. However, there is no direct evidence showing if taking thyroxin at different time point significantly affects treatment outcome. Besides, the response to thyroxin therapy differs among people. The purposes of this study are to evaluate the clinical significance of different time points of thyroxine intake and to search factors relating to thyroxin response of benign thyroid tumors. RESEARCH DESIGN AND METHODS - We will include patients who have benign thyroid tumors diagnosed with fine needle aspiration cytology and have normal thyroid function into our study. After informed consent, patients will be randomly assigned into two groups. Patients in the first group will take thyroxin one hour before breakfast until thyrotropin level stabilized between 0.5 and 1.0 mU/L for 3 months. Then thyroxin will be discontinued. Patients will restart thyroxin therapy three months later but after breakfast. Patients in another group will take thyroxin postprandial, discontinue thyroxin and then one hour before breakfast. Questionnaire interviews about diet and life style, blood samples and fine needle aspiration cytology samples will be obtained. Changes of thyroid nodules will be evaluated with thyroid echo. STATISTIC ANALYSIS - Descriptive data will be described as means and SDs for continuous variables, and analysis of variance and Chi-square tests were used for assessing the significances. A p-value below 0.05 was considered significant. Keywords: benign thyroid tumor, thyroxin, preprandial, postprandial.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Thyroid Nodule

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
under eltroxin
Intervention Type
Drug
Intervention Name(s)
Levothyroxin treatment
Intervention Description
Levothyroxin 100 micogram will be administered once daily 1 hour before meal of just after meal for 3 months, and the dose will be titrate to keep serum TSH level between 0.1~0.3 mU/L. It will be discontinued for 3 months. Then
Primary Outcome Measure Information:
Title
The size of thyroid nodules
Time Frame
3 months after levothyroxine treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: age between 20 to 90 years old Benign nodular goiter diagnosed with thyroid echo and fine-needle - aspiration cytology Exclusion Criteria: Age younger than 20 or older than 90 years old Pregnancy Allergy to eltroxin Taking other drugs which will have drug interaction with eltroxin patients with cardiovascular disease, hypertension, gastrointestinal disease
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shyang-Rong Shi, M.D.
Organizational Affiliation
National Taiwan University Hospital, Yun-Lin Branch
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Taiwan University Hospital
City
Dou-Liou city
State/Province
Yun-Lin County
Country
Taiwan

12. IPD Sharing Statement

Learn more about this trial

Levothyroxine Treatment in Thyroid Benign Nodular Goiter

We'll reach out to this number within 24 hrs